Chronic Low Back Pain
Conditions
Brief summary
Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.
Interventions
DEVICEtDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
OTHERLidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
OTHERControl cream
A neutral cream will be applied as a control.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Volunteers 21-60 years of age. * Meets the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician. * At least 4/10 clinical pain on the 11-point LBP VAS (criteria recommended by Dworkin et al.) * At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
Exclusion criteria
* Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections). * Complicated back problems (e.g., prior back surgery, medicolegal issues). * The intent to undergo surgery during the time of involvement in the study. * History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma, claustrophobia, epilepsy or acute eczema under the electrodes. * Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in an fMRI scanner. * History of medical or psychiatric illness. * History of substance / alcohol abuse or dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRI signal changes | 2 days; Sessions 5 and 7 |
| Gracely Scale pain rating changes | 2 days; Sessions 2 and 7 |
| resting state functional connectivity changes | 2 days; Sessions 5 and 7 |
Countries
United States
Contacts
Primary ContactGeorgia Wilson, BA
Outcome results
None listed